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Internet-Based, Randomized, Controlled Trial of Omega-3 Fatty Acids for Hyperactivity in Autism

https://doi.org/10.1016/j.jaac.2014.01.018Get rights and content

Objective

Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, Internet-based clinical trial design to evaluate the efficacy of this supplement.

Method

E-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the Internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist (ABC-H).

Results

During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (5.3 points) compared to the placebo group (2.6 points), but the difference was not statistically significant (1.9-point greater improvement in the omega-3 group, 95% CI = 2.2 to 5.2). Adverse events were rare and not associated with omega-3 fatty acids. Participant feedback was positive.

Conclusion

Internet-based, randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids.

Clinical trial registration information—Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT 01694667.

Section snippets

Participants

The study protocol was approved by the Committees on Human Research at the University of California, San Francisco and at Johns Hopkins University. The trial was registered before enrolling patients at clinicaltrials.gov (NCT 01694667) and took place between September 18, 2012 and December 31, 2012.

Recruitment was limited to children between the ages of 5 and 8 with some verbal ability (as defined by question 1 of the Social Communication Questionnaire or SCQ) who were enrolled in the

Results

During the 6-week recruitment period, e-mail recruitment notices were sent to 863 IAN members meeting initial age and ASD diagnostic criteria, and 118 families expressed interest and completed the online screening form. A total of 57 children from 28 states were deemed eligible and randomly assigned to study treatment. After the study was completed, it was discovered that a programming error had resulted in 3 participants being included who were not eligible: 1 patient in the omega-3 group had

Discussion

This study demonstrates the feasibility of conducting an IB-RCT in children with ASD. In just 6 weeks, 57 children from 28 states completed all eligibility criteria screenings and were enrolled. The response rate (118 responses to 863 e-mail invitations, or 13.7%) is a statistic that is most often reported for survey responses and not for acceptance to invitations for clinical trials. Although the response rate in this study is relatively low compared to those in published surveys, it is

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    This article was reviewed under and accepted by deputy editor John T. Walkup, MD.

    This work was supported by a grant from the Simons Foundation (SFARI 206484, S.B.) and by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through UCSF-CTSI Grant Number UL1 RR024131.

    Mr. Kalb served as the statistical expert for this research.

    Disclosure: Drs. Bent, Hendren, K. Law, and P. Law, and Ms. Zandi, Ms. Choi, Ms. Widjaja, Mr. Kalb, and Mr. Nestle report no biomedical financial interests or potential conflicts of interest.

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